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510(k) K891393

Device
ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT
Applicant
ORGENICS LTD.
510(k) number
K891393
Product code
LFZ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-23
Date received
1989-03-14
Regulation
866.3175
Classification name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BRUCE F MACKLER
Address
1120 Vermont Ave., NW Suite 600 Washington DC US 20005 20005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LFZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220949Architect CMV IgGAbbott Laboratories2022-10-27
K220911Elecsys CMV IgGRoche Diagnostics2022-10-12
K181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.2018-07-30
K163569Elecsys CMV IgMRoche Diagnostics2017-03-17
K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.2017-01-06
K142133ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGMRoche Diagnostics2014-10-24
K131605ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAYRoche Diagnostics2014-02-28
K040290DIASORIN LIAISON CMV IGM/IGGDiasorin S.P.A2005-06-01
K993952IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6Diagnostic Products Corp.1999-12-16
K982485SERAQUEST CMV IGMQuest Intl., Inc.1999-01-13
K984139THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THEZeus Scientific, Inc.1999-01-11
K983803THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THEZeus Scientific, Inc.1998-12-14
K982027MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAYDiaSorin, Inc.1998-11-25
K981163DIAMEDIX IS-CMV IGG TEST SYSTEMDiamedix Corp.1998-09-21
K971335QUANTA LITE CMV IGG ELISAInova Diagnostics, Inc.1997-12-01

Legacy Summary#

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FDA Review#

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